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Regulatory Affairs Manager

Regulatory Affairs Manager

BioTalentIrvine, CA, United States
2 hours ago
Job type
  • Full-time
Job description

Regulatory Affairs Manager (Hybrid Preferred)

📍 Location : Irvine, CA | 💼 Full-time | 🏥 Medical Device Industry

Join a passionate, mission-driven team dedicated to advancing medical device innovation and improving patient outcomes. As a Regulatory Affairs Manager , you will play a key role in coordinating and preparing regulatory submissions, partnering with cross-functional teams, and ensuring compliance with global regulatory standards. This role offers the opportunity to apply your expertise in a collaborative environment while directly contributing to life-saving technologies.

What You’ll Do

  • Develop and implement complex, global regulatory strategies for new and modified devices.
  • Prepare, review, and submit regulatory documentation for the U.S. and international markets.
  • Serve as the regulatory representative on multi-disciplinary project teams, aligning regulatory strategy with business objectives.
  • Interact with FDA, Notified Bodies, and international authorities throughout the device lifecycle.
  • Review product changes, labeling, advertising, and promotion for compliance with applicable regulations.
  • Support ongoing product maintenance, license renewals, and annual registrations.
  • Provide regulatory guidance during audits, inspections, and SOP development.
  • Consolidate and maintain communication with regulatory agencies and cross-functional stakeholders.

What We’re Looking For

  • Bachelor’s degree in a scientific, technical, or related field (advanced degree preferred).
  • 5–8 years of regulatory affairs experience in the medical device industry, preferably with Neurovascular or Cardiovascular Devices
  • Hands-on experience with U.S. and EU submissions, including HDE, IDE, and PMA applications .
  • Strong background in writing, project management, and regulatory coordination.
  • Proven experience interfacing with regulatory authorities through all stages of the product lifecycle.
  • Ability to thrive in a fast-paced, deadline-driven environment with cross-functional collaboration.
  • Proficiency with MS Office and Adobe Acrobat.
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